Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

AeroForm Tissue Expansion inflation with carbon dioxide by remote control

Saline Tissue Expansion inflated by needle injections of saline

The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.

AeroForm Tissue Expansion

A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.

Saline Tissue Expansion

Jeffrey A. Ascherman, M.D.

This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.

This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical study designed to compare the performance and safety of the AirXpander Tissue Expander System to currently cleared saline tissue expanders. Subject who meet the inclusion and agree to participate in the study will be enrolled and randomized to either the investigational arm (AirXpander Tissue Expander) or the control arm (standard saline tissue expander) using a 2:1 (AirXpander to saline) permuted block randomization stratified by investigational center and procedure (unilateral or bilateral). If the subject is having a bilateral procedure, the same type of expander will be implanted in each side. Subjects in both arms will be followed in the same manner until the explantation of the tissue expander(s) and exchange for permanent implant(s).

Patient Controlled Tissue Expansion for Breast Reconstruction

AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction

The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.

The median number of days taken to complete the expansion process.

AirXpanders, Inc.

All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99).

AEs assessed by investigators for severity, seriousness and relationship to device or procedure.

AEs coded to MedDRA standardized terms.

AeroForm Tissue Expansion inflation with carbon dioxide by remote control

AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.

Saline Tissue Expansion inflated by needle injections of saline

Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Device improvements occurred during the study with later subjects completing the study with a revised version of the device.

Results include all subjects treated in the study, regardless of device version.

Director of Clinical Affairs

The study was powered to show that the Treatment Success rate for the AeroForm System (πTreatment) was not worse than the rate for the saline expander (πControl) by more than 10% (-0.10 \< πTreatment - πControl).

Primary Analysis Population (Per Protocol Cohort) = Subjects with an expander implanted successfully with no major protocol violation (evaluated per breast). Subjects who had a bilateral procedure have each breast evaluated separately.

Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event

All breasts successfully exchange from expander to standard breast implant were analyzed for the length of time to complete the expansion process (days)

Expansion Days

Overall Study

Breast Diseases

Skin Diseases

Post-mastectomy patients undergoing expander reconstruction

Patient activated controlled expansion for post-mastectomy breast reconstruction

Patient Activated Controlled Expansion Device

Anthony Connell, M.D.

The purpose of this study is to determine whether a patient controlled tissue expander can improve the results and patient experience in breast reconstruction. The study hypothesis is that patient controlled expansion will lead to rapid and more comfortable outcomes than historical precedents.

Title: Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation

Design: Prospective, open-label, single-arm, feasibility trial Purpose: To evaluate the AirXpanders tissue expander in patients undergoing breast reconstruction surgery following mastectomy.

Enrollment: This feasibility trial will enroll up to 10 patients. Following enrollment of the first 5 patients, the sponsor will determine if additional subjects will be recruited to further evaluate treatment outcome.

Clinical Sites: Up to 3 sites and 3 surgeons will participate in this study. The surgeon(s) should have the necessary qualifications and sufficient experience (minimum of 12 breast tissue expanders placed per year) to participate in the trial.

Duration of Patient Participation: Eligible patients will be enrolled over approximately 2 months.

Patients will be instructed on the tissue expansion protocol pre-operatively and undergo post-operative clinical follow-up on a weekly basis or more frequently if deemed necessary by the treating surgeon.

Each patient will be followed through removal of the tissue expander.

Study Population:

The study population will consist of up to 10 patients. Eligible patients are females between the ages of 18 and 65 years who are planning to undergo breast reconstruction surgery following mastectomy. Eligible patients must be able to provide informed consent and understand protocol components.

Patient Activated Controlled Expansion (PACE) Trial

Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation

Symptoms and General Pathology

Nervous System Diseases

Behaviors and Mental Disorders

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Quality of Life

Pharmaceutical Solutions

All Drugs and Chemicals

Vasodilator Agents

Botulinum Toxins

Botulinum Toxins, Type A

abobotulinumtoxinA

Acetylcholine

Cholinergic Agents

Neurotransmitter Agents

100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast

5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast

Botulinum Toxin Type A

5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A

Placebo

Valerie Lemaine, MD

Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast reconstruction. Implant-based breast reconstruction is frequently achieved in two-stages. The first stage consists of the placement of a tissue expander after mastectomy. This is followed by a period of biweekly tissue expansions that can last several months. In the second stage, the tissue expander is removed in a surgical procedure and replaced with a permanent breast implant. Tissue expansion is a well-established breast reconstruction technique characterized by high success rates and high patient satisfaction. Despite the well-recognized advantages of this successful breast reconstruction technique, the subpectoral placement of a tissue expander is associated with significant pain and discomfort in the immediate post-operative period and during the phase of tissue expansion. Pectoralis major muscle spasm is a frequently reported problem during tissue expansion. Legeby et al. recently showed that women who underwent prosthetic breast reconstruction had higher pain scores and took more analgesics that those who did not choose post-mastectomy reconstruction.

In the past 10 years, publications on the use of botulinum toxin A (BTX-A) for pain relief in a wide array of clinical conditions have increased tremendously. BTX-A is one of the neurotoxins produced by Clostridium botulinum bacteria. By reversibly inhibiting neurotransmitter release, BTX-A has both analgesic and paralytic properties. The analgesic action of BTX-A was initially thought to be related to its effects on muscular contraction. However, a recent in vitro study of embryonic rat dorsal neurons did confirm that BTX-A inhibits release of substance P, a neurotransmitter associated with pain and inflammatory reactions. The presence of analgesic properties of BTX-A is increasingly supported by several clinical observations: pain relief with BTX-A injections has been reported for migraine headaches, chronic pelvic, chronic tennis elbow, and post-operative pain control for lower limb lengthening correction, among others.

This aspect has never been studied in breast cancer survivors who elect to pursue breast reconstruction with tissue expanders. Furthermore, physical function outcomes are important to consider with BTX-A use because the link between temporary muscle paralysis and improvements in participation in daily activities is not a given.

The investigators propose to complete a double-blinded prospective randomized controlled trial of women undergoing unilateral and bilateral mastectomies with immediate placement of tissue expanders, to establish the efficacy and safety of BTX-A in alleviating pain and in improving physical well-being during the expansion period.

Consecutively enrolled eligible women will be randomized into one of two different treatment groups: 1) Group receiving BTX-A, and 2) Group receiving a placebo. All consenting subjects will be randomized to receive either a single injection of 100 units of BTX-A, or a placebo (saline water), during surgery in the pectoralis major muscle on the operated side once the mastectomy and the breast reconstruction have been completed. Expected duration of subject participation is 4 months.

Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction

Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial

The numeric pain intensity scale (NPIS) will be completed at the preoperative visit and again at the first postoperative visit. The NPIS is a visual analog scale (VAS) commonly used to assess clinical pain. Subjects are asked to rate their pain on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

The Physical Well-Being scale of the BREAST-Q, Reconstruction module, will be used for this purpose. The BREAST-Q is a validated patient-reported outcome measure to accurately assess quality of life and patient satisfaction. The Reconstruction module Physical Well-Being scale has questions on the function and participation in activities before and after breast reconstruction. For this study, subjects were asked to answer 16 questions on how often they experienced each symptom, using score of 1 to 5, where 1 was none of the time and 5 was very often. Answers from these questions were combined to provide a total physical well-being score (for a total possible range of 16-80) for each patient at each visit. Lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction.

The amount of initial intraoperative fill volume in milliliters (mL) in the tissue expander at the time of surgery divided by the manufacturers recommended total tissue expander volume will be measured. Each breast will be measured separately.

The total number of tissue expansion visits completed post-operatively.

Measurement of total expansion volume in milliliters (mL).

The rate of reconstruction failure will be measured by the number of subjects who have tissue expander removal.

Allergan

Mayo Clinic

Principal Investigator

100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast

Botulinum Toxin Type A

Group A - Botulinum Toxin Type A

5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast

Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A

Group B - Placebo

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Body Mass Index (BMI)

A practice change from patients receiving paravertebral blocks preoperatively to intraoperative field blocks with liposomal bupivacaine;data not collected on postoperative oral narcotic consumption;study designed to detect 25% decrease in pain score.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patient Controlled Tissue Expansion for Breast Reconstruction	NCT01425268	Breast Cancer	AeroForm Tissue... Saline Tissue E...	18 Years - 70 Years	AirXpanders, Inc.
Patient Activated Controlled Expansion (PACE) Trial	NCT01009008	Breast Cancer Mastectomy Breast Reconstr...	Patient Activat...	18 Years - 65 Years	AirXpanders, Inc.
Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction	NCT01591746	Breast Cancer Pain, Postopera... BRCA1 Mutation BRCA2 Mutation Breast Diseases Neoplasms	Botulinum Toxin... Placebo	18 Years -	Mayo Clinic
Patient Activated Controlled Expansion (PACE) Trial	NCT01009008	Breast Cancer Mastectomy Breast Reconstr...	Patient Activat...	18 Years - 65 Years	AirXpanders, Inc.

Spots Global Cancer Trial Database for tissue expansion